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Individuals with chronic conditions like asthma, diabetes, and chronic obstructive pulmonary disease face an increased risk of developing RSV.
New study findings from Pfizer Inc announced positive top-line safety and immunogenicity of a single 120 µg dose of the respiratory syncytial virus (RSV) vaccine, Abrysvo (Pfizer Inc) among immunocompromised individuals 18 years and older that are at risk of developing RSV-lower respiratory tract disease (LRTD).1
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Abrysvo has previously received FDA approval for the prevention of RSV-LRTD among individuals 60 years and older, infants from birth up to 6 months, and pregnant individuals at 32 weeks through 36 weeks gestational age.1
“Immunocompromised adults, such as patients with cancer or autoimmune disorders, have a substantially increased risk of experiencing severe complications from RSV, yet there are currently no vaccines approved for those aged 18 to 59 in the U.S.,” Annaliesa Anderson, PhD, senior vice president and chief scientific officer of Vaccine Research and Development at Pfizer, said in a news release.1
Around 60,000 to 160,000 individuals are hospitalized due to RSV infection and 6000 to 13,000 deaths occur following the illness in the US alone. The virus can impact the lungs and airways, causing severe infection in infants, older adults, and individuals with chronic medical ailments. Study authors noted that RSV infection is divided in subgroups—RSV-A and RSV-B, which can alternate or co-circulate per season.1 According to the CDC, RSV infections typically increase in the fall and peak in the winter. However, during the 2021-2023 seasons RSV cases displayed an increase beginning as early as July.2
Individuals with chronic conditions like asthma, diabetes, and chronic obstructive pulmonary disease face an increased risk of developing RSV-associated LRTD. Study authors noted that about 9.5 individuals aged 18 to 49 residing in the US have 1 of the highlighted conditions, as individuals aged 50 to 64 years have a 24.3% increased risk. Abrysvo could provide protection against RSV-LRTD, as the RSV fusion protein is a major target of neutralizing antibodies, according to study authors.3
Trial Name: A Study to Assess the Safety, Tolerability, and Immunogenicity of RSVpreF in Adults at High Risk of Severe RSV Disease (MONET)
ClinicalTrials.gov ID: NCT05842967
Sponsor: Pfizer
Completion Date: March 2024
Trial Name: Study to Evaluate the Efficacy, Immunogenicity, and Safety of RSVpreF in Adults. (RENOIR)
ClinicalTrials.gov ID: NCT05035212
Sponsor: Pfizer
Completion Date (Estimated): June 2026
Researchers conducted a sub study B ongoing pivotal phase 3 MONeT (NCT05842967) clinical trial that assessed 2 doses of Abrysvo, administered 1 month apart in 4 groups of immunocompromised individuals. A total of 203 adults were included in the sub study and half were aged 18 to 59 and the other half were 60 and older, according to study authors.1
The data displayed that Abrysvo was tolerated throughout the trial, but a single 120 µg dose of Abrysvo produced a durable and neutralizing response to protect against RSV-A and RSV-B.1
The study authors noted that these results continued from findings presented at the June 2024 Advisory Committee on Immunization Practices that evaluated a single dose of Abrysvo compared to a placebo among adults 18 to 59 years old with chronic medical conditions. Individuals displayed RSV-A and RSV-B neutralizing responses non-inferior to the results displayed in the phase 3 RENOIR (NCT05035212) study that assessed the efficacy of Abrysvo among adults 60 years and older, according to study authors.1
“We are encouraged by the positive top-line data from this study, which provide important evidence that ABRYSVO has the potential to address a significant unmet need in this vulnerable population,” said Anderson, in a news release.1
